Akebia readies launch of anemia drug Vafseo; planning talks with FDA on pre-dialysis use
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Key takeaways:
- Akebia Therapeutics is preparing for a January 2025 launch of its anemia drug Vafseo for patients on dialysis.
- The drug maker plans to reopened talks with the FDA about the pre-dialysis population.
As Akebia Therapeutics announced plans to launch its anemia drug Vafseo to the dialysis community, company officials said they intend to work with the FDA for more testing of the drug for the pre-dialysis market.
The company received approval for to vadadustat (Vafseo, Akebia Therapeutics) in March for treating anemia in patients on dialysis, but the FDA turned down Akebia in 2022 for an application to use the drug in patients not on dialysis, citing higher major adverse cardiovascular events (MACE) compared with erythropoiesis-stimulating agents (ESAs).
“Less than 25% of patients in the non-dialysis population are being treated for anemia,” Nicholas Grund, chief commercial officer for Akebia, said during a second quarter earnings call with investors. “The value of having a product in the non-dialysis space is very high.”
The drugmaker told investors that it would be asking the FDA to reconsider data from its phase 3 PRO2TECT trial that tested use of Vafseo to treat patients with chronic kidney disease not on dialysis.
“The FDA [has] made statements that there is an ‘unmet medical need’ for treating anemia in patients with CKD,” John P. Butler, CEO of Akebia, said in an interview with Healio | Nephrology News & Issues. “That’s a positive development.
“Clearly, there is going to be the need for new clinical data,” Butler said. “That is our expectation” in seeking approval of Vafseo for the pre-dialysis population. “That is what we are working on now.
“Even if you look at stage 4 and 5 patients, with an eGFR below 30 [mL/min/1.73m2], which is where you really start to see significant anemia, that is a half a million patients” who could benefit from an anemia drug in a pill form, Butler said.
The company expects to hear feedback from the FDA about pursuing the non-dialysis population “by the end of the year,” Butler said.
Adoption cycle
Butler said he believes that Vafseo can become the standard of care for anemia management. “Most of the patients on dialysis are on a drug [for anemia treatment],” Butler told Healio | Nephrology News & Issues. “Physicians always go through an adoption cycle, and where do they want to adopt this product first? Home dialysis [represents] about 80,000 patients, and many physician don’t want to have patients come into the office to give them a shot, particularly for patients on home dialysis. A once-a-day oral product works perfectly there.”
The other area where nephrologists might find Vafseo of value is for patients who currently need high doses of ESAs. “Twenty-five percent of patients are not in the target range for hemoglobin, A lot of those patients are on high doses of ESAs, and we know that the higher the dose, the higher the MACE risk,” Butler said. “In our INNO2VATE trials, we didn’t see that high MACE risk.”
Financial results
Total revenues for the company’s second quarter dipped to $43.6 million compared with $56.4 million in the second quarter of 2023. “The decrease was driven by a reduction in license, collaboration and other revenue, which included a one-time $10 million up-front payment related to our Medice license agreement in the second quarter of 2023,” the company said in a press release. Medice Arzneimittel Pütter GmbH&Co.KG launched Vafseo in Germany and Austria in June and in the Netherlands in August, according to the press release.
Net product revenues were $41.2 million in the second quarter of 2024 compared to $42.2 million in the second quarter of 2023.
Akebia submitted its Transitional Drug Add-on Payment Adjustment (TDAPA) application to CMS and expects to have the designation by Jan. 1, 2025, Butler said. Akebia set the wholesale acquisition cost for Vafseo at $1,278 for a 30-day supply at the labeled starting dose, or approximately $15,500 per year, according to the press release.
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